Verification Validation Engineer

V&V Engineer - New Product

About Medasense

Medasense is redefining how pain is assessed and managed in healthcare. Our proprietary NOL® (Nociception Level) AI technology objectively quantifies pain response, enabling clinicians to personalize therapy, improve patient safety, and reduce variability in analgesic care. Our flagship platform,PMD-200™, is used in operating rooms and critical care environments where patients cannot communicate pain. Supported by strong clinical evidence and growing global adoption, PMD-200™ is commercially available across the United States, Canada, Latin America, Israel, and Europe.

About the Role

Medasense is seeking a V&V Engineer to lead verification and validation activities for a new medical device intended for high acuity clinical settings. The role covers system, hardware, software, and disposable sensor V&V, from planning through execution and reporting, in support of regulatory submissions in different jurisdictions.

Responsibilities

• Develop the V&V strategy and master plan for the new product in line with design controls (ISO 13485, FDA QMSR) and applicable standards.
• Translate product requirements and risk analysis outputs into verification protocols with full traceability.
• Write, review, and execute verification protocols at system, subsystem, and component level, including the disposable sensor.
• Execute and document testing against applicable standards, including IEC 60601 series (electrical safety, EMC) and ISO 10993 (biocompatibility) test programs, coordinating with external test labs.
• Analyze test results, document deviations and non-conformities, and drive resolution with R&D.
• Prepare V&V reports and documentation suitable for regulatory submission (e.g. 510(k) or equivalent).
• Support regression and design-change V&V during development and post-transfer.
• Plan, execute, and document process validation (IQ/OQ/PQ) in support of design transfer to manufacturing.

Requirements

• B.Sc. in Biomedical, Electrical, or Mechanical Engineering, or equivalent.
• 3+ years in V&V of medical devices under design controls.
• Hands-on experience writing and executing verification protocols and reports.
• Working knowledge of ISO 13485, ISO 14971, IEC 60601 series, and IEC 62366.
• Experience working with external test labs (safety, EMC, biocompatibility).
• Experience supporting regulatory submissions.

Advantages

• Experience with software V&V per IEC 62304.
• Experience with disposable or single-use components.
• Experience with devices used in high acuity settings (OR, ICU).
• Familiarity with statistical methods for test sample size justification.